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Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes

7. november 2019 oppdatert av: Celgene

A Multicenter, Randomized, Open-Label Study Comparing Three Alternative Dosing Regimens of Subcutaneous Azacitidine Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes

The purpose of this study is to determine if azacitidine, combined with Best Supportive Care (BSC), is effective in treating myelodysplastic syndromes (MDS) when given according to a different doses and dosing schedules.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Comparison/Control Interventions: The comparison is azacitidine at different doses and schedules.

Duration of Intervention: Treatment lasted for a maximum of 18 cycles, which is up to 24 months.

Studietype

Intervensjonell

Registrering (Faktiske)

151

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Bakersfield, California, Forente stater, 93309
        • Comprehensive Blood and Cancer Center, Research Department
      • Beverly Hills, California, Forente stater, 90211
        • Tower Cancer Research Foundation
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80907
        • Cancer Center of Colorado Springs, The Oncology Clinic, PC
      • Denver, Colorado, Forente stater, 80218
        • Rocky Mountain Cancer Centers, LLP
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20010
        • Washington Cancer Institute
    • Florida
      • New Port Richey, Florida, Forente stater, 34652
        • Florida Cancer Institute
      • Ocoee, Florida, Forente stater, 34761
        • Cancer Centers of Florida, P.A.
    • Illinois
      • Joliet, Illinois, Forente stater, 60435
        • Joliet Oncology-Hematology Associates, Ltd.
      • Peoria, Illinois, Forente stater, 61615-7828
        • Oncology/Hematology Associates of Central Illinois, PC
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46227
        • Central Indiana Cancer Centers
    • Louisiana
      • Metairie, Louisiana, Forente stater, 70115
        • Hematology & Oncology Specialists LLC
    • Michigan
      • Lansing, Michigan, Forente stater, 48910
        • Great Lakes Cancer Institute Breslin Cancer Center
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63141
        • The Center for Cancer Care and Research
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack University Medical Center
    • Ohio
      • Kettering, Ohio, Forente stater, 45409
        • Greater Dayton Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15224
        • Western Pennsylvania Cancer Institute
    • South Dakota
      • Aberdeen, South Dakota, Forente stater, 57401
        • Oncology Services of Aberdeen
      • Sioux Falls, South Dakota, Forente stater, 57105
        • Avera Cancer Institute Leukemia-Bone Marrow Transplant Center
    • Tennessee
      • Johnson City, Tennessee, Forente stater, 37604
        • McLeod Cancer and Blood Center
      • Nashville, Tennessee, Forente stater, 37203
        • The Sarah Cannon Research Institute
    • Texas
      • Bedford, Texas, Forente stater, 76022
        • Texas Oncology, P.A.
      • Dallas, Texas, Forente stater, 75230
        • Texas Cancer Center at Medical City
      • Fort Worth, Texas, Forente stater, 76104
        • Texas Oncology, PA
      • Fredericksburg, Texas, Forente stater, 78624
        • San Antonio Tumor & Blood Clinic
      • San Antonio, Texas, Forente stater, 78229
        • Cancer Care Centers of South Texas - HOAST
    • Virginia
      • Norfolk, Virginia, Forente stater, 23502
        • Virginia Oncology Associates - Lake Wright Cancer Center
    • Washington
      • Burien, Washington, Forente stater, 98166
        • Highline Medical Oncology
      • Edmonds, Washington, Forente stater, 98026
        • Puget Sound Cancer Center
      • Seattle, Washington, Forente stater, 98133
        • Puget Sound Cancer Center
      • Spokane, Washington, Forente stater, 99218
        • Cancer Care Northwest
      • Vancouver, Washington, Forente stater, 98684
        • Northwest Cancer Specialists, P.C.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of refractory anemia, refractory anemia with ringed sideroblasts and at least one of the following: a)Anemia with hemoglobin <110g/L and requires at least 1 unit packed red blood cell transfusions every 28 days; b)Thrombocytopenia with platelet counts <100 x 10^9/L; or c)Neutropenia with absolute neutrophil count <1.5 x 10^9/L.
  • OR, Refractory anemia with excess blasts or refractory anemia with excess blast in transformation, according to the French-American-British classification system for MDS.
  • At least 18 years of age.
  • Have a life expectancy of >7 months.
  • Unlikely to proceed to bone marrow or stem cell transplantation therapy following remission.
  • Have serum bilirubin levels less than or equal to 1.5 times the upper limit of the normal (ULN) range for the laboratory.
  • Have serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum glutamic-pyruvic transaminase (alanine aminotransferase) levels less than or equal to 2 x ULN.
  • Have serum creatinine levels less than or equal to 1.5 x ULN.

Exclusion Criteria:

  • Secondary MDS.
  • Prior treatment with azacitidine.
  • Any prior history of Acute Myeloid Leukemia (AML).
  • Malignant or metastatic disease within the previous 12 months.
  • Uncorrected red cell folate deficiency or vitamin B12 deficiency.
  • Hepatic tumors.
  • Radiation, chemotherapy, or cytotoxic therapy for non-MDS conditions in the previous 12 months.
  • Known or suspected hypersensitivity to azacitidine or mannitol.
  • Prior transplantation or cytotoxic therapy to treat MDS. Prior use of Revlimid and Thalomid allowed after 30 day washout.
  • Serious medical illness likely to limit survival to less than or equal to 7 months.
  • Treatment with androgenic hormones during the previous 14 days
  • Active viral infection with known human immunodeficiency virus or vial hepatitis Type B or C.
  • Treatment with other investigational drugs with the previous 30 days.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Aza-5
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
Legemiddel: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Eksperimentell: Aza-5-2-2
Azacitidine administered subcutaneously at 75mg/m^2 for 5days with 2 days off, then for an additional 2 days, on a 28 day cycle.
Legemiddel: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Eksperimentell: Aza-5-2-5
Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
Legemiddel: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Eksperimentell: Maintenance Aza 5 days q 4 weeks
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks.
Legemiddel: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.
Eksperimentell: Maintenance Aza 5 days q 6 weeks
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks.
Legemiddel: azacitidine

Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.
Tidsramme: Day 1 (randomization) to 6 months

Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD).

Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment (see Population Descrip)
Day 1 (randomization) to 6 months
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.
Tidsramme: Day 1 (randomization) to 6 months

IWG 2000 Criteria: Pretreatment=hemoglobin <110g/L or RBC transfusion-dependence, platelet count <100x10^9/L or platelet transfusion dependence, absolute neutrophil count <1.5x10^9/L.

Erythroid response: Major->20g/L increase in hemoglobin or transfusion independence. Minor- 10-20g/L increase in hemoglobin or >=50% decrease in transfusion requirements.

Platelet response: Major-absolute increase of platelet count by >=30x10^9/L or platelet transfusion independence. Minor->=50% increase in platelet count with net increase >10x10^9/L but <30x10^9/L.

(continued in Population Description)
Day 1 (randomization) to 6 months
Number of Participants With Overall Best Hematologic Response and Hematologic Improvement Based on IWG 2000 Criteria For MDS During the Initial Study Period
Tidsramme: Day 1 (randomization) to 6 months
Number of participants whose best hematological outcome was either complete remission (CR), partial remission (PR) (as determined by the investigator), or any hematologic improvement (based on the IWG 2000 criteria for MDS). See previous outcomes for detailed definitions.
Day 1 (randomization) to 6 months
Number of Participants Who Improved or Maintained The Hematologic Response From the Initial Study Period (Based on IWG 2000 Criteria For MDS) During the Maintenance Period
Tidsramme: 24 months
Hematologic response during the maintenance period are compared to the response in the initial study period. Initial response could have been a complete remission, a partial remission, stable disease or a hematologic improvement. Maintenance period best response is after randomization to a maintenance arm for those randomized, and is after the start of cycle 7 for those remaining on initial period treatment throughout the study.
24 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline Hemoglobin Values
Tidsramme: Day 1 (randomization)
The median values for hemoglobin based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for hemoglobin. Baseline values are used to compare to values following treatment.
Day 1 (randomization)
Change From Baseline in Hemoglobin at End of Initial Study Period (6 Months)
Tidsramme: 6 months
The difference between hemoglobin values at the end of the initial study period minus the hemoglobin values at baseline.
6 months
Change From Baseline in Hemoglobin at the End of the Maintenance Study Period
Tidsramme: 24 months
The difference between hemoglobin values at the end of the maintenance study period minus the hemoglobin values at baseline.
24 months
Baseline Platelet Values
Tidsramme: Day 1 (randomization)
The median values for platelets based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for platelets. Baseline values are used to compare to values following treatment.
Day 1 (randomization)
Change From Baseline in Platelets at the End of Initial Study Period (6 Months)
Tidsramme: 6 months
The difference between platelet values at the end of the initial study period minus the platelet values at baseline.
6 months
Change From Baseline in Platelets at the End of the Maintenance Study Period (Month 24)
Tidsramme: 24 months
The difference between platelet values at the end of the maintenance study period minus the platelet values at baseline.
24 months
Baseline Absolute Neutrophil Count (ANC) Values
Tidsramme: Day 1 (randomization)
The median values for ANC based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for ANC. Baseline values are used to compare to values following treatment.
Day 1 (randomization)
Change From Baseline in Absolute Neutrophil Count (ANC) at the End of Initial Study Period (6 Months)
Tidsramme: 6 months
The difference between ANC values at the end of the initial study period minus the ANC values at baseline.
6 months
Change From Baseline in Absolute Neutrophil Count (ANC) at the End of the Maintenance Study Period (Month 24)
Tidsramme: 24 months
The difference between ANC values at the end of the maintenance study period minus the ANC values at baseline.
24 months
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Tidsramme: 6 months
Shift table comparing the RBC transfusion status of patients at the end of the initial study period to the transfusion status at baseline.
6 months
Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)
Tidsramme: 6 months
Shift table comparing the platelet transfusion status of patients at the end of the initial study period to the transfusion status at baseline.
6 months
Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Tidsramme: 24 months
Shift table comparing the RBC transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.
24 months
Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)
Tidsramme: 24 months
Shift table comparing the platelet transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.
24 months
Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Initial Study Period
Tidsramme: 6 months
Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Initial study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).
6 months
Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Maintenance Study Period
Tidsramme: 24 months
Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Maintenance study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).
24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Celgene

Etterforskere

  • Studieleder: CL Beach, Celgene Corporation

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2005

Primær fullføring (Faktiske)

1. august 2008

Studiet fullført (Faktiske)

1. august 2008

Datoer for studieregistrering

Først innsendt

31. januar 2005

Først innsendt som oppfylte QC-kriteriene

31. januar 2005

Først lagt ut (Anslag)

1. februar 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AZA PH US 2004 CL003

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